European Biobank EBVD-EBPp

BRIEF PRESENTATION OF THE

The European Biobank on Vascular Diseases and its Sub-project European Biobank on PAD Patients (from here on called EBVD-EBPp) is a part of VAS’ research projects on vascular diseases. (VAS Web Site – This email address is being protected from spambots. You need JavaScript enabled to view it.).

The Biobank is part of the BBMRI.

WHAT ARE EBVD-EBPp’S PREREQUISITE?

Based on previous experience, the essential prerequisites for a European Vascular Biobank are:

A close link between clinical needs and research .

Confidence in the guarantees given to patients, in particular with regard to use of information for research purposes only (Vas has a Guarantors and an Ethics Committee for monitoring its activities).

Fully centralised organisation (sample storage and shipment, as well as material for the Ethics Committees, forms for Informed Consent already translated into the local languages, and so on), This is taken care of by the Scientific Co-ordination Centre in Milan (Research Center on Vascular Disease).

Contracts covering co-operation with Service Providers of certified quality. In fact, certified quality for each area not covered by the Network own specific skills.

All expenses centrally covered (guaranteed by Vas at the start of each project)

Development of educational initiatives (Vas already holds a annual Training and Refreshing event that has now reached its sixth year, in addition to the European Master in the field of Angiology/Vascular Medicine)

Direct involvement of patients (organised)

WHAT ARE EBVD-EBPp’S FEATURES?

Centres’ compliance, quality and ability in recruitments of PAD patients was tested by means of a previous project (called European Databank on PAD patients). More than 3,500 patients were evaluated all over Europe through a questionnaire and standardised procedures.Based on the above quoted prerequisites and on the results of the previous projects, the EBVD-EBPp has been thought to meet the characteristics resumed in the following summary:

EBVD-EBPp is:

- a European Biobank;- part of an independent Organization, but with close links with the Universities and European bodies- no-profit

In addition, EBVD-EBPp grantees:

- tried and tested co-operation among Angiology /Vascular Medicine Centres- guarantee of quality and consistency between the centres concerning the patients selection, diagnostic criteria and the collection of data (tried and tested in earlier research activities)- indissoluble link between the biobank and research, and clinical activities and training- involvement of Patient Groups

Also, EBVD-EBPp offers:

- a fully centralised organisation and complete meeting of any cost;- direct follow-up

Finally, EBVD-EBPp can rely on:

- Ethical guarantees (VAS Ethics Committee and Guarantors Committee, BBMRI, European and National rules/documents)- Compliance with all the necessary criteria for a Biobank in the vascular area as indicated above- BBMRI’s network

WHAT DATA ARE SUPPORTING THE EBVD-EBPp?

Through the surveys we have been able to collect several data stressing the importance of such a Biobank on Peripheral Arterial Disease (PAD):

PAD represents a chronic disease in progressive spreading especially because of the increase of the average age, it also is a high-risk pathology for acute events/mortality, since the very first stages (asymptomatic).

HOW IS THE EBPs ORGANIZED?

Vas is centralised in terms of direction, organisation and coverage of expenses>Centralisation of the material for submission to local Ethics Committees>Well-tested training at centres and direct follow-upDetailed on-line questionnaire at the Vas work portal (accessible with authorised ID’s and passwords for single researchers through VAS’ website).

VAS and the EBVD-EBPp’s organisation allow us to grant the patients the anonimity of personal information on three different levels:

- The collecting centre will be able to backtrack the patient having all her information and personal data- VAS’ headquarter will receive from the collecting centre the sample and the clinical data already anonymised so personal information confidentiality is totally granted- Once stored at the Bio-repository the sample is only associated to a barcode which allows the trackability of the sample but no clinical nor personal information are sent to the Bio-repository.

HOW TO JOIN – VAS European Vascular Biobank & EBVD-EBPp?

Interested Centres, Clinicians or Researcher can join according to the following instruction.

If you do not have any samples from vascular patients yet:

- by joining VAS (online application form);- by joining EBVD-EBPp project (email application request sent to This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.)

If you already have any samples from vascular patients:

- by writing directly to the Scientific Coordinator, in order to compare methodologies, criteria and visions. Once the due agreements are reached, VAS usually proposes two different ways to collaborate:

the samples and related data are sent to the centralized Biobank in Milan;

the samples are kept at the original Biobank and the related data are shared;

differents agreements can be reached based on each case’s necessity.

In any case, joining the project, the samples (independently from their physical location) will be assumed and become part of the VAS-Biobank.

WHAT AM I SUPPOSED TO DO ONCE I HAVE JOINED THE PROJECT?

- Get access (ID & password) from VAS to the online reserved areas;- Conform to VAS’ methodologies;- Recruit of PAD-patients and Controls;- Questionnaire file;- Blood-collection through the supplied kit and according to the given instruction;- Shipment of the sample by means of a currier supplied directly from VAS on simple request;

All costs will be met by VAS, no fees are to be paid by the collaborators.

WHAT CAN I FIND AT THE EBVD-EBPp?

- Detailed anonymous data of Patients and Controls;- Stocking of:

Whole BloodDNA

- Qualified Clinical Research Centres- Educational and Training Activities- Support and access to Worldwide Researches

IS THE COLLABORATION LIMITED TO EUROPE?

VAS is mainly European, but is maturing into a WorldWide organisation: continuous co-operation with non-European Centres is considered fundamental for the development of training and research.

This collaboration works also on VAS-Vascular European Biobank and on EBVD-EBPp.Criteria to participate are the same here above mentioned.